Medical Devices Events

January 2017
Jan22
The Soundlink ,for hearing aid accessories (China) As the increasing attention for hearing loss,and giving birth to a variety of types and brands of hearing aids in the world To adapt the development of hearing aids,Soundlink try to develop kind of products,and provide best service to our clients.
Posted by Iris Peng on January 22, 2017
May 2017
May23
MentorHealth Webinar Calendar of Upcoming Courses (Fremont) MentorHealth webinars are designed to offer professionals in the healthcare industry the knowledge they need in all the areas of the healthcare industry that enables them to excel in their professions #healthcare
Posted by Mentor Health on May 23, 2017
June 2017
Jun26
Overlap between Engineering and Psychology - 2017 (Fremont) The course will include Safety Analysis Considering Human Error, Human Factors Engineering, Behavior Based Safety Analysis.
Posted by Dhananjay Agarwal on April 17, 2017
Jun27
5 Key Tips for Superior Risk-based AML Compliance (New York) This webinar will cover what a risk-based approach to AML compliance means and the best practices for KYC and transaction monitoring. Reserve your seat now!
Posted by Compliance Inc. on May 30, 2017
Jun28
Form I-9 and E-Verify, Getting and Staying Compliant (2 HR sessions) (New York) This I-9 Webinar Training will include a review of the penalties ICE and Office of Special Counsel (OSC) can impose. Register for this live session now!
Posted by Compliance Inc. on May 31, 2017
Jun28
ICE Audits – What All Employers Should Fear? (New York) Speaker Bruce E. Buchanan will demonstrate the necessity of compliance audit procedures, how to correct I-9 errors, how to respond to an ICE audit and more.
Posted by Compliance Inc. on June 1, 2017
Jun28
Overlap between Engineering and Psychology - 2017 (Fremont) VBA is used to automate tasks that would otherwise have to be performed manually by pressing keys and selecting items with the mouse-and if that sounds like a macro-well it is.
Posted by Dhananjay Agarwal on April 17, 2017
Jun29
Lineament analysis and appropriate sampling and Quality 2017 (Seattle, WA) Understand the limitations of the current exploration process Learn to use lineament and satellite interpretation as a way to define where to concentrate their exploration efforts How to implement QA&QC procedures to guarantee the quality
Posted by Ronald Gardner on April 26, 2017
July 2017
Jul5
Use of Electronic Health Record Data in FDA regulated clinicals (New Hyde Park) This webinar will discuss FDA’s current recommendations on the use of electronic health record data in clinical investigations. Reserve your seat now! #electronichealthrecorddata
Posted by Compliance Inc. on June 9, 2017
Jul5
Statistical Concepts of Process Validation - 2017 (Fremont) Process validation is an important element in medical device manufacturing. This presentation looks at the underlying statistical concepts to perform an effective process validation.
Posted by Dhananjay Agarwal on May 3, 2017
Jul6
Learn how to Streamline your Payroll Processing Procedures 2017 (New York City, NY) This course covers a very broad range of topics from worker classification, to employee classification, to establishing methods and rates of pay, what must be included in the rate of pay, hours that must be compensated
Posted by Ronald Gardner on May 26, 2017
Jul6
Human Resource Risk Management Auditing 2017 (New York City, NY) HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series
Posted by Ronald Gardner on May 26, 2017
Jul6
Understanding Compliance Program Requirements -HIPAA 2017 (San Diego, CA) Being in compliance with HIPAA involves not only ensuring that you provide the appropriate patient rights and controls on your uses and disclosures of Protected Health Information; but that you also have the proper policies
Posted by Ronald Gardner on May 26, 2017
Jul6
How to Develop and Implement an Efficient and Effective (San Diego, CA) This 2 day seminar will explore how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas
Posted by Ronald Gardner on May 26, 2017
Jul6
Safety Management and OSHA Compliance (Washington, DC) Development of a safety program to save costs, delayed schedules and the human cost of injury or death. Safety management guidelines and techniques for the engineering, construction, and scientific professions.
Posted by Ronald Gardner on May 26, 2017
Jul6
Food - Current and Future Safety Regulations - 2017 (Fremont) Overview: With $49 billion worth of imported foods, the FDA and its regulatory allies oversee more than 420,000 domestic and foreign facilities.
Posted by Dhananjay Agarwal on May 3, 2017
Jul6
Excel - How to Create Resilient and Practical Budget (Fremont) Overview: David shares a wide range of helpful techniques, including how to separate inputs from calculations, streamline formula writing, preserve key formulas, and create both operating and cash flow budgets.
Posted by Dhananjay Agarwal on May 3, 2017
Jul10
Webinar on Current Issues and the Future of Electronic Medical Records (Fremont) Discussion will include key contextual and other factors that enhance effective implementation and use as well as a description of the likely evolution of health IT and EHRs in the next decade and the changes needed to realize the promise of EMRs. #medical
Posted by Mentor Health on May 15, 2017
Jul10
Ten-Step Process for COTS Risk-Based Computer System Validation 2017 (Singapore) This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments
Posted by Ronald Gardner on May 26, 2017
Jul10
Latest Guidelines for Combination Products Registration - 2017 (Fremont) Overview: During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products.
Posted by Dhananjay Agarwal on May 3, 2017
Jul11
Best Practices for Meeting the Challenges of New FDA (New York) This FDA compliance webinar will discuss ways to overcome the regulatory challenges based on the new requirements from FDA and EMA regulations. Book now!
Posted by AtoZ Compliance on June 12, 2017
Jul11
ACH Fraud - Detection and Prevention - 2017 (Fremont) Overview: This course reviews a wide variety of options and recommendations to assist attendees with developing their own internal protocols.
Posted by Dhananjay Agarwal on May 3, 2017
Jul11
Cyber Issues in Your Business Continuity Planning -2017 (Fremont) Overview: This webinar training will discuss how to create, test and implement an effective cyber Incident program to counter cyber threat and malware attacks.
Posted by Dhananjay Agarwal on May 3, 2017
Jul12
Validation and Part 11 Compliance of Computer Systems and Data 2017 ( Zurich, Switzerland) nalytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11
Posted by Ronald Gardner on May 26, 2017
Jul12
2017 HIPAA Changes (New York) This HIPAA compliance training will address major changes under the Omnibus Rule, Trump administration, and other applicable updates for 2017. Register now!
Posted by AtoZ Compliance on June 13, 2017
Jul12
Using Kanban/JIT Systems and Lean Elements to Run a Startup Plant (New York) Lean training - Learn how to create a demand-pull system to achieve the right balance of inventory and throughput throughout your startup operation. Book now!
Posted by AtoZ Compliance on June 13, 2017
Jul12
Successful Supplier Audits - 2017 (Fremont) Overview: One of the tools at your disposal to verify the supplier's acceptability is to audit its operation. This webinar is designed to provide the participants a working knowledge of supplier audits.
Posted by Dhananjay Agarwal on May 3, 2017
Jul13
Webinar on HIPAA Compliance Programs (Fremont) Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and what steps need to taken to mitigate risk #HIPAA
Posted by Mentor Health on May 15, 2017
Jul13
How to Perform a HIPAA Security Risk Assessment 2017 (Seattle, WA) I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you).
Posted by Ronald Gardner on May 26, 2017
Jul13
All the Relevant Regulations and Guidelines 2017 (San Jose, CA) A thorough understanding of the complexities involved All the relevant regulations and guidelines Real life examples of how to register and maintain various types of combination products
Posted by Ronald Gardner on May 26, 2017
Jul13
Statistical Process Control -Verification, Validation, Risk Management ( SFO, CA) ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality. Statistical Process Control
Posted by Ronald Gardner on May 26, 2017
Jul13
Terminally ill Patients and the ‘Right to Try’ (New York) Review FDA’s legal framework for providing seriously ill patients access to investigational new drugs
Posted by AtoZ Compliance on June 14, 2017
Jul13
FDA-Regulated Environment Development Team - 2017 (Fremont) Overview: The Agile approach is well established in other industries adoption of Agile in medical device development has been increasing in the past five years.
Posted by Dhananjay Agarwal on May 3, 2017
Jul17
FDA and ISO Compliance Personnel Training - 2017 (Fremont) Overview: To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them.
Posted by Dhananjay Agarwal on May 3, 2017
Jul18
Webinar on Successful Health Care Systems Implementation Process (Fremont) These tools and processes have been equally and successfully applied to the implementation of large, complex systems and smaller, simpler systems for large, multidepartment organizations and for small health care organizations. #healthcare
Posted by Mentor Health on May 15, 2017
Jul18
Medical Affairs Essentials Summer School 2017 (Lisbon, Portugal) 1. Soft Skills Excellence in KOL Engagement 2. Medical Writing Excellence & Enhancing Publication Standards 3. Market Access & Health Economics for Medical Affairs 4. Late-Phase Evidence Development #medicalaffairs
Posted by Lucia Kamhalová on May 22, 2017
Jul18
HIPAA, Ransomware &Cyber Criminal Chaos Prevent (New York) This HIPAA and Ransomware Training will discuss how to use the HIPAA Rules to prevent, prepare, respond and recover from Ransomware attacks. Register now!
Posted by AtoZ Compliance on June 15, 2017
Jul18
Process Validation - Statistical Process Control - 2017 (Fremont) Overview: Process knowledge and understanding is the basis for establishing an approach to process control and related instruction sets in the Batch Record for each critical step of the process operation and the overall process results.
Posted by Dhananjay Agarwal on May 3, 2017
Jul18
Laboratory Accreditation -Getting There is Just the Beginning - 2017 (Fremont) Overview: Accreditation is not a guarantee of analytical competency. Getting accredited is just the beginning. The journey begins with defining the laboratory's operating principals and policies.
Posted by Dhananjay Agarwal on May 3, 2017
Jul20
Six Steps in Master HIPAA Compliance 2017 (Washington DC) The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion
Posted by Ronald Gardner on May 26, 2017
Jul20
Human Factors Methods and Device Product Life Cycle 2017 (Washington, DC) The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents
Posted by Ronald Gardner on May 26, 2017
Jul20
Statistics for the Non-Statistician 2017 (Boston, MA) If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. Statistics of course, requires constant practice.
Posted by Ronald Gardner on May 26, 2017
Jul20
ISO14971- Risk Management and Quality System Integration 2017 (Washington, DC) Gaps and/or incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they..
Posted by Ronald Gardner on May 26, 2017
Jul20
Leadership Management Academy 2017 (Boston, MA) Too often, we focus on getting things done and results and miss working on our self-development. Let's face it: this is how we get paid yet this is also how we keep falling behind when it comes to our careers. It's time to get ahead!
Posted by Ronald Gardner on May 26, 2017
Jul20
FDA Process Validation for Applied Statistics 2017 (Chicago, IL) In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, "...the collection and evaluation of data, from the process design stage through commercial production...
Posted by Ronald Gardner on May 26, 2017
Jul20
Fixed Dose Combination Products. The Promise and Possibilities (New York) The objective of this pharmaceutical training is to provide full account of the challenges involved in Combination Product Development programs. Book now!
Posted by AtoZ Compliance on June 19, 2017
Jul20
Expectations of Regulatory & Validation Master Planning - 2017 (Fremont) Overview: This presentation will cover the importance of master planning. The FDA and other regulatory bodies expect these to be among the Quality System documentation.
Posted by Dhananjay Agarwal on May 3, 2017
Jul21
Sharing Information with Family and Friends under HIPAA (Fremont) One of the toughest situations that healthcare professionals can face is whether or not to share information about an individual with the individual's family and friends involved with the individual's care. #HIPAA
Posted by Mentor Health on May 15, 2017
Jul24
Adapting Hospital Employed and Private Practice Compensation (Fremont) This presentation will highlight the key challenges and then provide practice insights into how to adapt both hospital employed and private practice compensation models to the new realities of medicine today. #health
Posted by Mentor Health on May 15, 2017
Jul25
Webinar On Compensation-Focused Compliance (Fremont) This webinar will discuss strategies for ensuring physician compensation plans and compensation-focused governance processes support compliance. #healthcare
Posted by Mentor Health on May 15, 2017
Jul25
Mitigating Risk: How to Prevent HIPAA Data Breaches (Fremont) With a substantial increase HIPAA data breaches, organizations must understand the requirements to safeguard protected health information. In 2015, almost 120,000,000 individuals were affected by HIPAA data breaches. #HIPAA
Posted by Mentor Health on May 15, 2017
Jul25
Aseptic Technique Understanding and Cleanroom Behavior - 2017 (Fremont) Overview: Compounding sterile products are made utilizing aseptic technique. Aseptic technique is a microbiological term referring to the prevention of microorganism contamination.
Posted by Dhananjay Agarwal on May 3, 2017
Jul25
Latest FDA Changes to the Process Bullet Proof 510k - 2017 (Fremont) Overview: The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.
Posted by Dhananjay Agarwal on May 3, 2017
Jul27
Training and Development in the Life Sciences and Regulatory (Philadelphia, PA) Developing Technical Training in the Life Sciences is a 2-day seminar that addresses the unique challenges of developing and managing training in Life Sciences companies. The Life Sciences pose unique challenges to training developers.
Posted by Ronald Gardner on May 26, 2017
Jul27
Medical and Device Performance and Regulatory and Statistical (Miami, FL) This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation,
Posted by Ronald Gardner on May 26, 2017
Jul27
HIPAA Security Policies and Procedures an Audits 2017 (Washington, DC) Day one sets the stage with an overview of the HIPAA regulations including HIPAA Breach Notification and the process that must be used to determine whether or not a breach is reportable, and then continues with presentation of the specifics
Posted by Ronald Gardner on May 26, 2017
Jul27
Overview of Employment Related Risk Management and HR Audits 2017 (Philadelphia, PA) HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions
Posted by Ronald Gardner on May 26, 2017
Jul27
Complaints, Adverse Event Reporting, and Recalls 2017 (Philadelphia, PA) Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem. Manufacturers must identify
Posted by Ronald Gardner on May 26, 2017
Jul27
FDA, GMP Requirements for Exploratory Clinical Studies 2017 (Philadelphia, PA) Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required.
Posted by Ronald Gardner on May 26, 2017
Jul27
How to Develop and Implement an Efficient and Effective (Philadelphia, PA) Principles and Audit Planning Planning and preparation Internal audits are critical element of your quality management system. Your approach must be both systematic and documented to remain compliant
Posted by Ronald Gardner on May 26, 2017
Jul27
Control Change in Medical Device Engineering - 2017 (Fremont) Overview: This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming.
Posted by Dhananjay Agarwal on May 3, 2017
August 2017
Aug1
Cyber Attacks, Beyond Disaster Recovery - 2017 (Fremont) Incident Response Plans today have to consider a myriad of possible attack methods to ensure Plans appropriately mitigate unique threats. #Education
Posted by Dhananjay Agarwal on June 2, 2017
Aug3
Effective Supplier Qualification Program - 2017 (Fremont) FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct. FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns. #Education
Posted by Dhananjay Agarwal on June 2, 2017
Aug4
Validation Program to a Building from Top to Bottom - 2017 (Fremont) How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program? #Education
Posted by Dhananjay Agarwal on June 2, 2017
Aug8
Webinar on Structuring and Auditing Physician Employment Agreements (Fremont) This webinar will focus on the Stark Law's underlying technical requirements and key tenets of defensibility as they apply to physician employment arrangements. #healthcare
Posted by Mentor Health on May 15, 2017
Aug8
FDA Inspection and Respond to 483 & How to Prepare them - 2017 (Fremont) In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection. #Education
Posted by Dhananjay Agarwal on June 2, 2017
Aug10
Environmental Monitoring Program at FDA Regulations - 2017 (Fremont) Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring Program fits into the Regulations. Explain the basis of the Four (4) Phases of Clean room transitional monitoring. #Education
Posted by Dhananjay Agarwal on June 2, 2017
Aug14
HIPAA Covered Entities: Managing the HIPAA Business Associate Process (Fremont) The webinar will cover how to find out if business associates have the necessary technical, physical and administrative safeguards in place to protect shared protected health information. #HIPAA
Posted by Mentor Health on May 15, 2017
Aug17
HIPAA Hybrid Entities (Fremont) This session will examine the options and the issues in choosing to be a Hybrid Entity or not and assist organizations in making the decision and implementing the results of the decision. #HIPAA
Posted by Mentor Health on May 15, 2017
Aug17
ISO 14971 Hazard Analysis at Medical Device - 2017 (Fremont) FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. One of the techniques described in ISO 14971 is Hazard Analysis. #Education
Posted by Dhananjay Agarwal on June 2, 2017
Aug21
Emerging Payment Model (Fremont) Providers should attend this session to learn how to optimize their performance under a bundled payment paradigm and how to negotiate bundled service agreements to their best advantage. #health
Posted by Mentor Health on May 15, 2017
Aug29
Structuring and Auditing Physician Leases (Fremont) The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided. #healthcare
Posted by Mentor Health on May 15, 2017
September 2017
Sep5
2017 Webinar on HIPAA and Personal Devices (Fremont) This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. #HIPAA
Posted by Mentor Health on June 9, 2017
Sep7
Structuring and Auditing Medical Director Arrangements 2017 (Fremont) The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided. #Compliance
Posted by Mentor Health on June 9, 2017
Sep14
Best Practices & Effective Cleaning Validation Procedures - 2017 (Fremont) Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. #Education
Posted by Dhananjay Agarwal on June 2, 2017
Sep19
Webinar on 2017 HIPAA Audits - an Insider's Perspective (Fremont) This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur #HIPAA
Posted by Mentor Health on June 9, 2017
Sep21
FDA inspectional - Training Practices for FDA Compliance - 2017 (Fremont) This webinar will give a good understanding of FDA requirements for training and provide recommendations for implementation. #Education
Posted by Dhananjay Agarwal on June 2, 2017
Sep28
Webinar on HIPAA for HR - Some Good News for Employers (Fremont) The definition of "genetic Information" under HIPAA and the Genetic Information Nondiscrimination Act includes a wide variety of information about family history and more, which must be avoided by the health plan. #HIPAA
Posted by Mentor Health on June 9, 2017
Sep28
Key Stark Law Considerations webinar by MentorHealth (Fremont) This webinar will focus on the Stark Law's underlying technical requirements and key tenets of defensibility as they apply to physician practice acquisitions. #Compliance
Posted by Mentor Health on June 9, 2017
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